InnoCore job opening: Quality Assurance Manager

The position

As the Quality Assurance (QA) Manager you give effect to and are responsible for InnoCore’s quality policy and system. In close collaboration with the QA officer, Manager Operations and Quality Control and department quality coordinators, you ensure adherence to internal quality procedures. Furthermore, you ensure that the internal quality procedures are compliant to the applicable current national and international regulations and guidelines (EMA, FDA, ICH). In addition, you support and advice project managers regarding quality issues within projects where applicable. Ideally, you can also function as Prevention Worker (preventie medewerker, article 13 of the Dutch Arbo law) and as such are responsible for the InnoCore safety policy. Together with the emergency response team members (BHV), department managers and lab managers, you ensure adherence of employees to the InnoCore safety policy in order to provide a safe working environment. You coordinate and keep up to date the risk inventarisation and evaluation (R&IE) and follow up. Furthermore, you challenge, support and advice the organization regarding safety issues and risk assessments where applicable You report to the Chief Executive Officer (CEO) and will have 1 direct report (QA officer, 0.6 fte).

The challenge

In your role as a Quality Assurance Manager you:

• Develop, maintain, improve and keep up to date the InnoCore quality system in such a way that it complies with the applicable national and international regulations and guidelines (EMA, FDA, ICH) and is appropriate for the various InnoCore activities and products.
•  Identify, initiate and manage quality improvement projects. Page 2 of 3
• Manage document control activities.
• Manage complaints and recalls and ensure appropriate follow up.
• Manage the internal and supplier audit program.
• Manage and host regulatory inspections and customer quality audits and assure proper follow up.
• Inform and maintain contact with regulatory bodies regarding the applicable licenses or authorizations and with customers regarding quality agreements.
• Provide advice and assistance to the different departments, projects and the management team in quality and regulatory matters.
• Represent QA in customer or internal projects when required.
• Release of products intended for non-clinical safety studies (GLP Toxicology). QA Release of products intended for human use (GMP). Release of analysis results for third parties.
• Stimulate quality awareness throughout the organization together with the QA officer and department quality coordinators, and manage the quality (re)training program.

If applicable, in your role as Prevention Worker you:

• Develop, maintain, improve and keep up to date the InnoCore safety policy, procedures and supporting documents (e.g. RI&E) in such a way that they comply with the applicable national regulations and guidelines (Arbeidsomstandigheden wet).
•  Identify, initiate and manage safety improvement projects.
• Review and assure appropriate documentation and follow up of the registration of incidents, near misses and observation of unsafe situations.
• Manage and host regulatory inspections and assure proper follow up.
• Inform and maintain contact with regulatory bodies regarding the applicable licenses or authorizations.
•  Provide advice and assistance to the different departments, projects and the management team in safety matters.
• Stimulate safety awareness throughout the organization together with the emergency response team members, department managers and lab managers.

Skills and competencies

In addition to a MSc or PhD degree in analytical (bio)chemistry/polymer chemistry, biotechnology, (bio)pharmaceutical sciences or a related discipline, you:

• Have at least 5 years’ experience in a pharmaceutical company
• Have a broad knowledge – gained through at least 5 years of relevant experience - of quality systems, audits and inspections in the pharmaceutical industry, including knowledge of regulatory landscape related to drug development and IP/licensing.
• Have experience and affinity with safety, health and environment policies, awareness and culture. Page 3 of 3
• Are able to set directions, embrace cross-functional collaboration, inspire and delegate to ensure all InnoCore employees are clear on their individual contributions to safety, the quality system and quality in general, and are encouraged to take their own responsibility.
• Have the ability to analyze situations, diagnose problems and identify the key issues including establishing and evaluating alternative courses of action and produce a logical, practical and acceptable solution.
•  Have the ability to stay up-to-date with the latest updates of regulations, developments and best practices..
• Have the ability to transfer results or solutions effectively and inspiring to others in writing or verbally, and the ability to convince others by sound advocacy and inquiry.
• Have a drive to get things done with a strong client focus and you consistently seek ways to improve performance.
• Look for opportunities to develop for yourself and your team skills and add some new ones.
• Have the ability to develop a broad big-picture view of InnoCore and its mission and you can link strategic objectives to work priorities.
• Continuously explore and meet client needs, manage client expectation and drive effective relationships inside and outside the organization.

What InnoCore Pharmaceuticals offers

We offer a challenging position in a modern and well equipped laboratory where you will become part of a young and ambitious team of co-workers. Remuneration will be according to standards in the pharmaceutical industry. At InnoCore we are committed to offer the best possible environment for our employees, where people are challenged and supported to further develop themselves. We provide a collaborative and creative environment where each member of the team feels encouraged to contribute to our processes, decisions, planning and culture.

Further information and how to apply

For more information please contact J. Kampinga (CEO) at +31 (0)50 575 3100. You can email your curriculum vitae and motivation letter to jobs@innocorepharma.com.